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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ INJECTOR LUER LOCK N35J; INTRAVASCULAR ADMINISTRATION SET
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BECTON DICKINSON, S.A. BD PHASEAL¿ INJECTOR LUER LOCK N35J; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 515009
Device Problem Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/03/2021
Event Type  malfunction  
Event Description
It was reported that during preparation of endoxan with bd phaseal¿ injector luer lock n35j the needle was exposed.There was no report of patient or user impact.The following information was provided by the initial reporter, translated from (b)(6) to english: the customer's verbatim report is that the needle didn't return to the original position during preparation of endoxan.The customer states that there wasn't anything wrong with the hcp's handling of the product.
 
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
 
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
 
Event Description
It was reported that during preparation of endoxan with bd phaseal¿ injector luer lock n35j the needle was exposed.There was no report of patient or user impact.The following information was provided by the initial reporter, translated from (b)(6) to english: the customer's verbatim report is that the needle didn't return to the original position during preparation of endoxan.The customer states that there wasn't anything wrong with the hcp's handling of the product.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: 2022-feb-28.H6: investigation summary: samples received for investigation, an injector attached to a syringe.The claimed injector was connected to a connector, but the sample arrives disconnected and the injector with the needle exposed and the safety sleeve grips removed.The safety sleeve grips are removed from their place; most likely caused by user misuse of the device during connection/disconnection of the phaseal device against the mat component.Through visual inspection, it is noted that the injector needle is exposed and the injector handles are displaced from their original location.The product undergoes visual and functional inspections throughout the manufacturing process to ensure the quality and functionality of the device, including verification that all critical dimensions are within specification.The lot number is unknown for the injector product, therefore device history record review (dhr) or quality notification review (qn) could not be performed.
 
Event Description
It was reported that during preparation of endoxan with bd phaseal¿ injector luer lock n35j the needle was exposed.There was no report of patient or user impact.The following information was provided by the initial reporter, translated from japanese to english: the customer's verbatim report is that the needle didn't return to the original position during preparation of endoxan.The customer states that there wasn't anything wrong with the hcp's handling of the product.
 
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Brand Name
BD PHASEAL¿ INJECTOR LUER LOCK N35J
Type of Device
INTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer (Section G)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13114584
MDR Text Key285622167
Report Number3003152976-2021-00869
Device Sequence Number1
Product Code ONB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number515009
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/03/2021
Initial Date FDA Received12/29/2021
Supplement Dates Manufacturer Received02/24/2022
Supplement Dates FDA Received03/24/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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